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ERYTHROMYCIN ETHYLSUCCINATE GRANULES FOR ORAL SUSPENSION 500MG/5ML

Active substance(s): ERYTHROMYCIN ETHYL SUCCINATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Erythromycin Ethylsuccinate Granules for Oral Suspension
125mg/5ml, 250mg/5ml, 500mg/5ml
(erythromycin ethylsuccinate)



Read all of this leaet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any
possible side effects not listed in this leaet. see section 4.
What is in this leaet
1. What Erythromycin ethylsuccinate granules for oral suspension is and what it is used for.
2. What you need to know before you take Erythromycin ethylsuccinate granules for oral
suspension
3. How to take Erythromycin ethylsuccinate granules for oral suspension
4. Possible side effects
5. How to store Erythromycin ethylsuccinate granules for oral suspension
6. Contents of the pack and other information
1. WHAT ERYTHROMYCIN ETHYLSUCCINATE GRANULES FOR ORAL SUSPENSION IS
AND WHAT IT IS USED FOR.
Erythromycin ethylsuccinate granules for oral suspension contains an active ingredient
erythromycin which belongs to a group of medicines called macrolide antibiotics.
Erythromycin ethylsuccinate granules for oral suspension are used to prevent and treat infections
such as:
• Throat and sinus infections;
• Chest infections, such as bronchitis and pneumonia;
• Ear infections;
• Mouth and dental infections;
• Eye infections;
• Skin and tissue infections, such as acne;
• Stomach and intestinal infections;
• Prevention of infection following burns, operations or dental procedures;
• Other infections, such as sexually transmitted diseases, bone infections or scarlet fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN ETHYLSUCCINATE
GRANULES FOR ORAL SUSPENSION
Do not take Erythromycin ethylsuccinate granules for oral suspension if you are:
• allergic (hypersensitive) to erythromycin or other macrolide antibiotics such as clarithromycin or
azithromycin or any of the other ingredients in the product (listed in section 6 and end of section
2)
• taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine,
domperidone,
• are currently taking a medicine called
ergotamine or dihydroergotamine (used to treat migranes) as this may cause serious
side effects while taking erythromycin;
terfenadine or astemizole or mizolastine (widely taken for hayfever and allergies),
domperidone (for nausea (feeling sick) and vomiting (being sick)), cisapride (for
stomach disorders) or pimozide or amisulpride (for psychiatric conditions) while
receiving erythromycin, as combining these drugs can sometimes cause serious
disturbances in heart rhythm. Consult your doctor for advice on alternative medicines
you can take instead;
simvastatin (used to lower cholesterol and triglycerides (type of fat) in the blood);
tolterodine (used for treating overactive bladder with symptoms of urinary frequency,
urgency, and leakage).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Erythromycin ethylsuccinate granules for
oral suspension if you:








are taking colchicine (used for treatment of gout and arthritis) as this may cause serious side
effects while taking erythromycin;
have any liver problems or have been told that any drugs you are taking can cause liver
problems;
have previously experienced diarrhoea following the use of antibiotics;
are pregnant and have been told that you have a sexually transmitted disease called syphilis. In
this case erythromycin may not be effective for preventing the transfer of this infection to your
body. Consult your doctor before receiving erythromycin. Alternatively if you were treated for
early stages of syphilis during your pregnancy, and your child is under 1 year and is prescribed
erythromycin, consult your doctor before giving erythromycin to your child;
are treating a young child with antibiotics and they are irritable and vomit when fed, you should
contact your physician immediately;
suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your
doctor before receiving erythromycin;
are taking erythromycin with 'statins' such as simvastatin or lovastatin (used to lower
cholesterol) as serious side effects can occur.

Other medicines and Erythromycin ethylsuccinate granules for oral suspension
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines.
• warfarin (thins the blood)
• cisapride (used for stomach disorders)
• pimozide (used in the treatment of psychiatric disorders)
• clarithromycin (antibiotic used to treat certain infections)
• ergotamine or dihydroergotamine ( for migraine)
• theophylline (helps breathing)
• cilostazol (for blood circulation problems)
• rifabutin (for tuberculosis)
• sildenal (for erectile dysfunction)
• vinblastine (for cancer)
• antifungals e.g. uconazole, ketoconazole and itraconazole
• colchicine (for gout)
• protease inhibitors (used to treat viral infectionse.g. saquinavir)
• oral contraceptives
• cimetidine and omeprazole (used to treat acid reux and other related conditions)
• methylprednisolone (used to help supress the body's immune system - this is useful in treating a
wide range of conditions)
• St John's Wort (a herbal medicine used to treat depression)
• Verapamil (used to treat high blood pressure and chest pain)
• Other drug interactions include: bromocriptine (used to treat Parkinson's disease), digoxin or
disopyramide or quinidine (all heart drugs), hexobarbitone, midazolam (used as a sedative),
cyclosporin or tacrolimus (used following organ transplants), alfentanil, zopiclone or triazolam
(induces sleep)
Phenytoin or carbamazipine, valproate (drugs for epilepsy), lovastatin (a cholesterol lowering
agent), your doctor should monitor you appropriately and may adjust your dosage of erythromycin
as necessary.
Do not take simvastatin, tolterodine, mizolatine, amisulpride, terfenadine, domperidone or
astemizole (for the treatment of hayfever and other allergies) if you have been prescribed
Erythromycin ethylsuccinate granules for oral suspension.
If you or your child goes for any medical tests, tell your doctor that you are taking Erythromycin
ethylsuccinate granules for oral suspension, as this may interfere with some test results.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to become pregnant. Erythromycin passes into
breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant and treated with an oral erythromycin tablets for early syphilis. Please consult
your doctor as erythromycin mat not be effective in preventing infection to the baby.
Driving and using machines
Erythromycin ethylsuccinate granules for oral suspension is not expected to afect your ability to

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drive or operate machinery.
Erythromycin ethylsuccinate granules for oral suspension contains sucrose
This medicine contains sucrose which may be harmful to your teeth. If you know you have an
intolerance to some sugars, contact your doctor before taking the suspension.
3. HOW TO TAKE ERYTHROMYCIN ETHYLSUCCINATE GRANULES FOR ORAL
SUSPENSION
Always take Erythromycin ethylsuccinate granules for oral suspension exactly as your doctor has
told you. The pharmacist's label should tell you how much to take and how often.
For oral use only.
125mg/ 5ml
Adults, elderly &
4 x 5 ml teaspoonfuls,
children (over 8 years)
4 times a day.
Children between 2 and 2 x 5 ml teaspoonfuls,
8 years
4 times a day.
Infants and babies under 2 x 5 ml teaspoonfuls,
2 years
twice a day.

250mg/5ml
500mg/5ml
2 x 5ml teaspoonfuls, 1 x 5ml teaspoonfuls,
4 times a day.
4 times a day.
1 x 5ml teaspoonfuls,
4 times a day.
1 x 5ml teaspoonfuls,
twice a d a y .

Children 2 - 8 years and < 2 years: 30mg/kg/day in divided doses. For severe infections up to
50mg/kg/day in divided doses.
Continue to take this medicine until the course is completed or until your doctor tells you to stop; do
not stop taking your medicine, even if you feel better. if you stop the treatment too early your
problem could come back.
If you take more Erythromycin ethylsuccinate granules for oral suspension than you should
If you accidently take more medicine in one day than your doctor has told you to, or if a child has
taken some of the medicine by mistake, contact your doctor or go to your nearest hospital emergency department immediately. An overdose of Erythromycin ethylsuccinate granules for oral
suspension could cause temporary hearing loss, nausea, vomiting and diarrhoea.
If you forget to take Erythromycin ethylsuccinate granules for oral suspension
If you miss a dose, take the suspension as soon as remember and carry on as before.
If it is almost time for your next dose, skip the missed dose and continue as usual (do not take a
double dose to make up for the forgotten dose).
If you have any further questions on the use of this product, ask your doctor o pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all other medicine, Erythromycin ethylsuccinate granules for oral suspension can cause side
effects, although not everyone gets them.
STOP taking this medicine and seek medical help IMMEDIATELY if you experience any of the
following reactions:
• difculty breathing;
• fainting;
• swelling of the face, lips or throat;
• skin rashes;
• severe skin reactions including large uid-lled blisters, sores and ulcers;
• ulcers in the mouth and throat, as these may be signs of an allergic reaction
Other side effects which may occur are:
• diarrhoea which may be severe or prolonged and may contain blood or mucus;
• feeling sick or being sick;
• increase in a particular type of white blood cells (eosinophilia);
• stomach pains; these may be a symptom of an inamed pancreas (pancreatitis);
• ringing in the ears (tinnitus);
• reversible loss of hearing (usually associated with higher doses or in patients with kidney
problems);
• various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes
(jaundice) or pale stools with dark urine;
• chest pains;
• abnormal heart rhythms (including palpitations);














fever;
anorexia;
confusion;
ts (seizures);
vertigo (problems with balance that can result in feelings of dizziness or sickness - particularly
on standing);
hallucinations (seeing or hearing things that aren't there);
feeling generally unwell (malaise);
inammation of the kidneys (a condition known as interstitial nephritis);
low blood pressure;
serious skin rashes that may involve blistering and can cover large areas of the torso, face and
limbs (conditions known as Stevens Johnson syndrome, toxic epidermal necrolysis and
erythema multiforme);
vomiting and irritability in young children between the age of 1 month and 12 months;
visual impairment/blurred vision (Mitochondrial optic neuropathy).

Contact your doctor immediately if you experience a serious skin reaction: a red scaly rash with
bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is
not known (cannot be estimated from the available data)
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaet. You can also report side effects directly via the Yellow Card Scheme:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide more information on the safety of this
medicine.
5. HOW TO STORE ERYTHROMYCIN ETHYLSUCCINATE GRANULES FOR ORAL
SUSPENSION
Keep this medicine out of the sight and reach of children.
Unopened bottle: Do not store above 25°C. Store in the original container and keep tightly closed.
Do not use suspension after the expiry date is stated on the label.
Reconstituted suspension: Store 2- 8°C and use within 14 days.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to protect
the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Erythromycin ethylsuccinate granules for oral suspension contains
The active substance is erythromycin ethylsuccinate.
The other ingredients are croscarmellose sodium, sodium citrate, banana avour (E4210 SD),
quinoline yellow (E104), sodium saccharin, colloidal anhydrous silica, sucrose (see Section 2
'Important information about some of the ingredients of Erythromycin ethylsuccinate granules for
oral suspension').
What Erythromycin ethylsuccinate granules for oral suspension looks like and contents of
the pack
The granules for oral suspension is a free owing, yellow coloured granules, with a characteristic
banana odour which on reconstitution forms a thick, smooth suspension. The product is available in
three strengths (125mg/5ml, 250mg/5ml and 500mg/5ml), supplied in 100ml brown bottles with a
plastic screw-on cap.
Marketing Authorisation Holder and Manufacturer
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom
This leaet was last revised in {02/2018}

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